Docetaxel in Treating Patients With Solid Tumors

Phase 2

Completed

• Conditions: Bladder Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Breast Cancer; Head and Neck Cancer; Lung Cancer
• Interventions: Drug: docetaxel

• Registration Number: NCT00003565
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.

Detailed Description

OBJECTIVES:

* Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors.

* Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations.

* Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-01
• Study Completion: 2008-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
docetaxel	docetaxel	OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

Trial Locations

Locations (74)

Northeast Alabama Regional Medical Center; 🇺🇸 Anniston, Alabama, United States

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States

Veterans Affairs Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

Veterans Affairs Medical Center - Washington, DC; 🇺🇸 Washington, District of Columbia, United States

Broward General Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

Scroll for more (64 remaining)